Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (Nasdaq: AZN) announced on Monday that it has received US Food and Drug Administration (FDA) approval for Tezspire (tezepelumab), developed in collaboration with biotechnology company Amgen, as an add-on maintenance treatment for adults and adolescents aged 12 and over with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

The approval, which broadens Tezspire's indication to a second epithelial-driven inflammatory disease, was supported by results from the Phase III WAYPOINT trial. Data showed that Tezspire significantly reduced nasal polyp severity, nearly eliminated the need for surgery and lowered systemic corticosteroid use compared to placebo. Results were presented at the 2025 American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress and published in The New England Journal of Medicine.

Tezspire is the first and only biologic targeting thymic stromal lymphopoietin (TSLP) to gain approval for CRSwNP. Safety and tolerability in the WAYPOINT study were consistent with previous findings, with the most common adverse events being COVID-19, nasopharyngitis and upper respiratory tract infection.

Regulatory applications for CRSwNP are under review in the EU, China, Japan and other markets, following a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

Tezspire is already approved for severe asthma in more than 60 countries, including the US, EU and Japan, and continues to be evaluated in Phase III trials for chronic obstructive pulmonary disease and eosinophilic oesophagitis.

Under the 2012 collaboration agreement, AstraZeneca and Amgen share development costs and profits equally, with AstraZeneca leading development and Amgen managing manufacturing.